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FDA Finalizes Guidance Documents on Biosimilar Product Development

Thursday, May 21, 2015  
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The FDA recently issued revisions to three draft guidance documents on biosimilar product development. The guidance documents were originally drafted in February 2012 following the 2010 passage of the Biologics Price Competition and Innovation Act (BPCI).

The three documents include:

• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
• Quality Considerations in Demonstrating Biosimilarity to a Therapeutic Protein Product to a Reference Product
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

As posted online by the Regulatory Affairs Professionals Society, the first guidance is a question-and-answer document outlining how FDA interprets the BPCI, including its provisions on exclusivity, biosimilarity and interchangeability. The guidance outlines many high-level expectations for biosimilar products.

A second document explains the "quality considerations" companies need to take into account when attempting to demonstrate biosimilarity between a biosimilar product and its reference product.

The guidance can almost be summarized in a sentence, helpfully supplied by FDA on page six of the guidance document:

"Sponsors should use appropriate analytical methodology that has adequate sensitivity and specificity to detect and characterize differences between the proposed product and the reference product."

Regulators go on to explain in the guidance document that companies are required by law "to include data supporting the analytical similarity of the proposed biosimilar product to the reference product." The rationale for the assessment should be "clearly described" in the submission, FDA added.

Finally, the third guidance document explains FDA's recommended approach for demonstrating biosimilarity using scientific data.

"As set forth in the PHS Act, data derived from analytical studies, animal studies, and a clinical study or studies are required to demonstrate biosimilarity unless FDA determines an element unnecessary," FDA explains in the guidance.

FDA encourages sponsors to utilize what it calls a "stepwise approach" to demonstrate biosimilarity. "At each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product and identify next steps to try to address that uncertainty," regulators explained.

FDA said it will consider the "totality of the evidence" when assessing a sponsor's evidence of biosimilarity.

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